🇺🇸 Febuxostat IR in United States

FDA authorised Febuxostat IR on 13 February 2009

Marketing authorisation

FDA — authorised 13 February 2009

  • Application: NDA021856
  • Marketing authorisation holder: TAKEDA PHARMS USA
  • Local brand name: ULORIC
  • Indication: TABLET — ORAL
  • Status: approved

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Frequently asked questions

Is Febuxostat IR approved in United States?

Yes. FDA authorised it on 13 February 2009.

Who is the marketing authorisation holder for Febuxostat IR in United States?

TAKEDA PHARMS USA holds the US marketing authorisation.